Shield TX (UK) Ltd.

Main purpose To determine serum total iron, transferrin saturation, and the concentrations of maltol and maltol glucuronide in plasma and urine, and to evaluate the iron absorption and pharmacokinetics of maltol in blood and urine. Secondary purpose To determine blood transferrin, total iron binding capacity, ferritin, blood routine indexes and reticulocyte count, and preliminarily evaluate the iron-related pharmacodynamics of maltol iron capsules after single and multiple administrations. To evaluate the safety of single and multiple oral administration of maltol iron capsules in subjects with iron deficiency.

Primary study objective: To evaluate the efficacy of oral ferrous maltol compared with placebo in the treatment of IDA in subjects with inflammatory bowel disease (IBD) who are refractory/intolerant to oral ferrous iron preparations (OFP) by measuring the change in hemoglobin (Hb) concentration from baseline to week 12. Secondary study objective: To evaluate the safety of ferrous maltol in the treatment of IBD and IDA subjects who are refractory/intolerant to OFP for 12 weeks.